Summary
The FDA issued a Class II for EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 by Philips Ultrasound Inc. Reason: Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which.
Details
Source
Device Recall
External ID
Z-0123-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Lot/Code Info: Software Versions: 6.0, 7.0, 7.0.3
Quantity Affected: 107
Reason for Recall
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
Distribution
US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-21
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Ultrasound Inc has 111 FDA actions in our database, including 111 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound Inc have FDA actions?
Philips Ultrasound Inc has 111 FDA actions in our database, including 111 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0123-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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